RecruitingNot ApplicableNCT06553235

RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention


Sponsor

Aarhus University Hospital

Enrollment

84 participants

Start Date

Dec 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of the study is to investigate whether treating insomnia using app-based cognitive behavioral therapy for insomnia (CBT-I) can improve cognitive impairment in breast cancer survivors compared to an active control group (sleep hygiene education). The study will also explore if CBT-I is associated with changes in the brain and in inflammation. The investigators will recruit approximately 84 participants with insomnia and cognitive impairment who have completed breast cancer treatment within 1-5 years.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (RESET-BRAIN) is testing an app-based program to help breast cancer survivors who are struggling with sleep problems (insomnia) and "chemo brain" (cognitive issues like memory and concentration difficulties after cancer treatment). The intervention is based on cognitive behavioral therapy for insomnia (CBT-I) and cognitive rehabilitation, delivered via a smartphone app. **You may be eligible if...** - You are 18 or older and have completed primary breast cancer treatment within the last 1–5 years (ongoing hormone therapy is fine) - You score above 10 on the Insomnia Severity Index OR meet criteria for insomnia disorder - You report significant memory or concentration problems on quality-of-life measures **You may NOT be eligible if...** - You have another sleep disorder (other than insomnia), neurodegenerative disease, or psychiatric condition that affects sleep or cognition - You are pregnant or on maternity leave - You have had a cancer recurrence or new cancer - You do not speak Danish well enough to participate - You have previous experience with CBT-I or shift work Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive Behavioral Therapy for Insomnia (CBT-I)

CBT-I is a multi-component intervention consisting of sleep restriction, stimulus control therapy, relaxation therapy, cognitive therapy, and sleep hygiene education

BEHAVIORALSleep hygiene education

\- Sleep hygiene education includes information on lifestyle factors (diet, exercise, substance use) and environmental variables (noise, light, temperature) affecting sleep quality.


Locations(1)

Aarhus University Hospital

Aarhus N, Denmark

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NCT06553235


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